Promentis Pharmaceuticals Announces Positive Results for Phase 2A Study of SXC-2023 Targeting Novel Glutamatergic Mechanism and Completion of Enrollment for Phase 2 Trichotillomania Study

Completed 28-patient Phase 2A behavioral biomarker study shows significant improvements in impulse control and 120-patient Phase 2 multi-center study in trichotillomania is fully enrolled

MILWAUKEE, WI, USA I October 31, 2019 IPromentis Pharmaceuticals, Inc., a privately-held biopharmaceutical company developing innovative therapies for neuropsychiatric disorders, today announced it has successfully completed a behavioral biomarker study for its lead compound, SXC-2023, and has finished enrolling patients in a Phase 2 multi-center study in its first indication, trichotillomania. Promentis is developing SXC-2023 and other compounds that engage system xc-, a unique astrocytic central nervous system target that addresses glutamatergic imbalance to treat trichotillomania and other highly prevalent neuropsychiatric diseases marked by deficits in impulse control.

The principal aims of the now-completed Phase 2A behavioral biomarker study were to demonstrate psychodynamic activity and further evaluate the safety and tolerability of SXC-2023 in adult subjects. The study reveals a clear effect associated with SXC-2023 administration in measures of impulse control closely related to trichotillomania and other indications of interest to the Company, and reinforces the attractive safety profile of SXC-2023. The results indicate the potential benefits of SXC-2023 on important aspects of cognitive dysfunction implicated across a wide range of CNS disorders. 

The aim of Promentis' now fully-enrolled multi-center Phase 2 study in trichotillomania is to evaluate the efficacy, safety and tolerability of three oral doses of SXC-2023 in adult patients with moderate to severe trichotillomania. Trichotillomania is a highly prevalent but underrecognized impulse control disorder that has no approved treatments. It is characterized by recurrent hair pulling, leading to noticeable hair loss and a substantial adverse impact on quality of life. The Phase 2 trial is a double-blind randomized study conducted in 13 centers with more than 120 patients divided into four cohorts (three active-doses and a placebo). The study will examine measurements of trichotillomania symptom severity, impulsivity and cognitive parameters and measures of overall patient mental health and well-being.

Promentis has moved quickly with these two Phase 2 programs and had previously announced the successful completion of its Phase 1 clinical studies in a press release dated November 16, 2018.

"We are excited to have made such significant progress in our clinical program and very pleased to have fully enrolled our Phase 2 trichotillomania program on schedule," said Dr. Thomas Beck, CMO of Promentis. "The results of the behavioral biomarker study, coupled with SXC-2023's excellent safety profile, present the possibility of a ground-breaking new therapy."

Glutamatergic dysfunction is a hallmark feature of many neuropsychiatric indications, including a broad range of impulse control disorders, which is Promentis' initial therapeutic focus. The company is also exploring additional CNS indications where glutamatergic imbalance contributes to impaired functioning and activation of system xc-, a unique astrocytic target, can result in therapeutic benefit.

About Promentis Pharmaceuticals
Promentis Pharmaceuticals, Inc. is a privately-held biopharmaceutical company developing innovative therapies for impulse control and other neuropsychiatric disorders. Promentis' drug development efforts are focused on a unique approach to addressing glutamatergic imbalance. The Company's first indication is trichotillomania, a highly prevalent disorder for which there is no approved drug therapy, and for which there are no other known treatments in development.

Promentis is led by Klaus Veitinger, M.D., Ph.D. (CEO, Chairman of the Board for Promentis and OrbiMed Venture Partner). The team also includes Tom Beck, M.D. (Chief Medical Officer and Board Member for Promentis and F-Prime Capital Executive Partner), Daniel Lawton (President and Board Member) and Chad Beyer, Ph.D. (Senior VP R&D).

About Trichotillomania and Other Obsessive-Compulsive and Addictive Disorders
Obsessive-compulsive and related disorders, as defined by DSM-5, represents a broad category of neuropsychiatric disease, including trichotillomania, excoriation (skin-picking) disorder and OCD. Trichotillomania is a disabling and underrecognized condition characterized by recurrent hair pulling despite repeated attempts to stop the behavior, leading to noticeable hair loss and substantial adverse impact on quality of life. Trichotillomania is associated with a range of psychosocial problems, including low self-esteem, social anxiety, avoidance of intimacy, occupational impairment and an overall decrease in quality of life. In addition, a significant number of trichotillomania patients ingest their hair after pulling, which can lead to life-threatening gastrointestinal blockages requiring surgery. 

Alterations in glutamate signaling within brain regions implicated in impulse control and executive function have been proposed to contribute to the underlying pathology of trichotillomania, as well as other obsessive-compulsive disorders, addictive disorders and other CNS conditions. Trichotillomania has been estimated to affect more than 1% of the US population. No medications are approved by the US Food and Drug Administration for the treatment of trichotillomania, nor are there any other known treatments in development. For more information regarding trichotillomania, see:  https://promentispharma.com/technology/trichotillomania.

About System xc- and SXC-2023
System xc-, a release mechanism expressed by astrocytes in the brain, represents a unique therapeutic target for glutamatergic modulation.  SXC-2023, Promentis' novel compound, activates system xc-thereby modulating glutamate signaling to normalize brain function. SXC-2023 appears to be safe and selective, with its impact focused on impulse control and executive function.
SXC-2023 is one of a family of compounds designed to target system xc- and has been granted composition of matter patent protection in the US and other jurisdictions.

SOURCE: Promentis Pharmaceuticals

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